Trial Outcomes & Findings for Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States (NCT NCT04163341)

NCT ID: NCT04163341

Last Updated: 2024-09-19

Results Overview

We defined feasibility as the total number of patients approached in order to accrue the final study sample size of n=60.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Duration of recruitment phase (9 months)
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	CETA Protocol Adapted Common Elements Treatment Approach: The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement.	Enhanced Usual Care Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Overall Study STARTED	30	30
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	CETA Protocol Adapted Common Elements Treatment Approach: The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement.	Enhanced Usual Care Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States

Baseline characteristics by cohort

Measure	CETA Protocol n=30 Participants Adapted Common Elements Treatment Approach: The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement.	Enhanced Usual Care n=30 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.	Total n=60 Participants Total of all reporting groups
Age, Continuous	39.8 years STANDARD_DEVIATION 9.4 • n=5 Participants	44.0 years STANDARD_DEVIATION 13.4 • n=7 Participants	41.9 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex/Gender, Customized Male	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex/Gender, Customized Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex/Gender, Customized Transgender Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Transgender Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex/Gender, Customized Additional sex or gender	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of recruitment phase (9 months)

Population: The analysis population for this outcome measure (feasibility of recruitment) is larger than the study population as we included all patients approached for screening (n=92) to reach our study sample (n=60).

We defined feasibility as the total number of patients approached in order to accrue the final study sample size of n=60.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=92 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Feasibility of Recruitment	92 participants	—

PRIMARY outcome

Timeframe: At treatment exit (approximately 9 months post-baseline)

Population: Client acceptability was only measured for participants in the CETA arm since this outcome reflects their overall satisfaction with the intervention. This population includes the 25 participants who completed the exit interview \~9 months post-baseline

Client acceptability will be assessed via the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire, with a minimum value of 8 and a maximum score of 32. A higher score indicates greater client acceptability.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=25 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Client Acceptability	29.3 units on a scale Standard Deviation 3.0	—

PRIMARY outcome

Timeframe: At the end of CETA completion or withdrawal, across all CETA participants

Population: The analysis population includes the total number of clients assigned to each counselor.

Counselor fidelity to CETA will be rated by the trainer based on the trainer's supervisory experience working with CETA counselors. After all CETA patients complete the study, the trainer will rate up to 5 cross-cutting aspects of CETA delivery and 13 CETA components targeting specific symptoms for fidelity. The trainer will rate the degree of confidence on a scale of 0 ("Not at all") to 4 ("Completely") that the counselor was routinely delivering each cross-cutting aspect or component of CETA with fidelity, for those aspects and components that the trainer had experience supervising the counselor in. The fidelity rating will be calculated separately for the 2 CETA counselors and reported as the mean score across the number of CETA aspects and components rated by the trainer. Higher scores indicate greater fidelity to CETA.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=24 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=6 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Fidelity	3.3 units on a scale Standard Deviation 0.72	3.0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 4 months post-baseline

Population: The analysis population includes all participants with a collected 4-month viral load.

HIV RNA viral load <200 copies/mL

Outcome measures

Measure	No Arm Assignment in Screening Phase n=21 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=27 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Number of Participants Suppressed HIV RNA Viral Load	13 Participants	18 Participants

SECONDARY outcome

Timeframe: 9 months post-baseline

Population: This analysis population includes all participants with a completed viral load at 9 months post-baseline.

HIV RNA viral load <200 copies/mL

Outcome measures

Measure	No Arm Assignment in Screening Phase n=24 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=26 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Number of Participants With Suppressed HIV RNA Viral Load	17 Participants	17 Participants

SECONDARY outcome

Timeframe: From baseline to 12 months post-baseline

Health Resources and Services Administration (HRSA) attendance measure: Engaged in care if attended >=2 HIV primary care visits >= 90 days apart in the 12 months after baseline.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=30 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=30 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
HIV Appointment Attendance	22 Participants	22 Participants

SECONDARY outcome

Timeframe: 4 months post-baseline

Population: The analysis population includes all participants with a completed interview at 4 months post-baseline

Patient Health Questionnaire-9 (PHQ-9) score; minimum score is 0, maximum score is 27, with higher scores meaning a worse outcome.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=27 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=28 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Depressive Symptoms	11.1 score on a scale Standard Deviation 6.8	9.8 score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: 4 months post-baseline

Population: The analysis population includes all participants with a completed interview at 4 months post-baseline

Generalized Anxiety Disorder-7 (GAD-7) anxiety subscale score; minimum score is 0, maximum score is 21, with higher scores meaning a worse outcome.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=27 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=28 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Anxiety Symptoms	10.4 score on a scale Standard Deviation 5.4	9.3 score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 4 months post-baseline

Population: The analysis population includes all participants with a completed interview at 4 months post-baseline.

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5); minimum score is 0, maximum score is 80, with higher scores meaning a worse outcome.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=27 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=28 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Post-traumatic Stress Symptoms	33.7 score on a scale Standard Deviation 19.2	28.9 score on a scale Standard Deviation 17.3

SECONDARY outcome

Timeframe: 4 months post-baseline

Population: The analysis population includes all participants with a completed interview at 4 months post-baseline.

The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); each substance is scored separately. The minimum score is 0, maximum score is 39, with higher scores meaning a worse outcome. For this outcome, we will report substance use symptoms at 4 months post-baseline for the substance with the highest score at baseline only.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=27 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=28 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
Substance Use Symptoms	10.0 score on a scale Standard Deviation 8.1	7.9 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: From baseline to 12 months post-baseline

Population: Analysis population includes all participants with data on their total number of HIV care visits collected from baseline to 12 months post-baseline.

Mean kept visit proportion: Total number of kept visits HIV clinical care visits divided by total number of missed plus kept HIV clinical care visits.

For one individual: The numerator in this proportion is all the scheduled HIV clinical care visits a participant attended from baseline to 12-months post-baseline.The denominator in this proportion is all the scheduled HIV clinical care visits a participant attended plus all the scheduled HIV clinical care visits a participant did not attend or 'missed' from baseline to 12-months post-baseline.

For each arm: We calculated the mean kept visit proportion per study arm by adding each individual kept visit proportion and dividing by the total number of participants in each arm.

Outcome measures

Measure	No Arm Assignment in Screening Phase n=28 Participants Participants approached for screening and eligibility are not linked to the participants who enrolled and were eventually randomized to 1 of the 2 study arms.	Enhanced Usual Care n=30 Participants Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment.
HIV Kept Visit Attendance	0.74 Proportion of HIV care visits Standard Deviation 0.27	0.70 Proportion of HIV care visits Standard Deviation 0.27

Adverse Events

CETA Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Mugavero

University of Alabama at Birmingham

Phone: 202-966-5822

Email: mmugavero@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place